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Medical device regulation and cryo-ing wolf

In this second piece for our Monash University Summer Vacation Scholarship series, School of Public Health and Preventative Medicine prize winner Darci Bucheli looks at medical device regulation and the cryotherapy craze.

Bucheli and classmate Lucy Romanoff spent their summer completing a brief research project under the supervision of Associate Professor Ken Harvey. Both have prepared reports for Croakey, and you can read Romanoff’s piece on the supplements industry here.


Darci Bucheli writes:

Whole-body Cryotherapy is the latest medical-device trend to take the health and fitness world by storm, with celebrities and social media influencers hopping on the bandwagon. The treatment, which involves exposing the whole-body to dry air of typically -110 to -160˚C for 2-3 minutes, purports to do just about everything.

Cryotherapy claims to have beneficial effects on weight loss, muscle soreness, pain relief, injury recovery, ageing, skin conditions and autoimmune diseases and will only set you back around $75 for a 2-minute session.

A recent ICIJ investigation into medical devices highlighted the importance of proper regulation and transparent complaint outcomes for such technologies. But how are we actually faring?

In Australia, medical devices are regulated by the Therapeutic Goods Administration (TGA). They must be ‘included’ by the sponsor in the Australian Register of Therapeutic Goods (ARTG) before they can be legally sold. Promotion must also comply with the Therapeutic Goods Advertising Code.

Such measures are designed to protect consumers and health professionals against potentially dangerous goods and/or misleading or deceptive claims.

Regulatory requirements of the TGA depend on the risk classification of the device. Higher risk devices, such as hip implants, must undergo a ‘conformity assessment’. These are largely conducted by for-profit certifiers, and human trials are usually not required, a far cry from the stringent approval procedure for high-risk medicines.

Only some higher-risk devices are independently audited by the TGA.

Medical devices regarded as lower-risk, like cryotherapy chambers, are rarely audited. Sponsors merely certify that the device meets a checklist of ‘essential principles’. These include that the device must be suitable for its intended purpose, and that the benefits gained outweigh any undesirable effects arising from its use.

A regulatory maze

To confirm whether a medical device has been regulated by the TGA, consumers and health professionals need to be able to check if it is included on the ARTG, and whether there have been upheld complaints.

Our investigation of cryotherapy devices revealed difficulties in cross-referencing the ARTG for medical devices.

For example, the Polarbare Club Cryo states it uses a ‘JUKA Cryosauna’, but a search of the ARTG for this term failed to locate such a device.

Further online inquiries revealed the manufacturer of Juka cryotherapy devices to be Polish firm Przedsiebiorstwo Produkcyjno-Handlowe Juka, but no match was found on the ARTG for a device from this company. A broader search of the ARTG for ‘cryotherapy’ did find a similar device from this outfit, but sponsored by a different cryotherapy company called Minus 110 Pty Ltd.

The Polish website included the details of an Australian distributor, Griffith Industries, and through direct contact we eventually confirmed that the device used by Polarbare Club Cryo was not included on the ARTG, meaning its supply and promotion was illegal.

Shortcomings and solutions

The ARTG would be easier to navigate if the search function allowed for a manufacturer’s name and the advertised device name as options.

It would also be helpful if an included device had its ARTG number prominently displayed in its advertising, similar to the inclusion of AUST L & AUST R numbers on pack shots of advertised medicines.

Tracking down the details of upheld TGA complaints about medical devices is also difficult. There is no search function on TGA upheld complaint outcomes that enable device names or advertisers to be readily found, even for complaints regarded as critical.

The current TGA system stands in stark contrast to the search function and detailed determinations of the former Complaints Resolution Panel (CRP).

Given cryotherapy devices have caused harm and there is a paucity of evidence for the benefits claimed, do they satisfy the TGA’s essential principle? We have submitted a complaint to the TGA about the claims made by Polarbare Club Cryo; it has yet to receive an outcome.

In the meantime, consumers are advised to conduct their own research and seek independent medical advice before subjecting themselves to potentially dangerous health fads like cryotherapy.

Darci Bucheli was awarded a 2018 Monash University SPHPM Summer Vacation Scholarship

She undertook research into the illegal promotion and supply of cryotherapy chambers in Australia, supervised by Associate Professor Ken Harvey

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